ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes

We have adopted this International Scientific Guideline - ICH M7 (R2); EMA/CHMP/ICH/5072766/2021

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas effective date: 30 September 2023

Categories: ICH | Multidisciplinary | Antineoplastic and immunomodulating agents

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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